Clinical trial · Interventional
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: * What is the safe dose of KQB548? * Does KQB548 decrease the size of the tumor? * What happens to KQB548 in the body?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KQB548 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Escalation
- interventionNames
- Drug: KQB548
Primary outcomes (1)
- measure
- Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
- timeFrame
- Up to 30 months
- description
- Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs
Secondary outcomes (13)
- measure
- Plasma Concentration-time curve (AUC)
- timeFrame
- Up to 30 months
- measure
- Maximum plasma concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation * Progressed on, or intolerant to at least one prior line of systemic standard of care therapy * Measurable disease according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor * History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications * Poorly controlled ascites and/or pleural effusion * Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer * Requires treatment with a proton-pump inhibitor
References
Publications (0)
Data not yet available